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A study to evaluate the long-term safety and effectiveness of balinatunfib in adults with Crohn's disease or ulcerative colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to investigate the long-term safety and effectiveness of balinatunfib in adults living with Crohn's disease or ulcerative colitis. These are types of inflammatory bowel disease, which is a condition that causes long-lasting swelling and irritation in the digestive tract. Participants in the study will receive either balinatunfib, which is an oral medication taken by mouth in the form of a film-coated tablet, or a placebo.

The research focuses on how different doses of the medication affect people over an extended period. During the course of the study, the way the body reacts to the treatment and any potential side effects will be monitored to ensure safety and how well the body tolerates the drug.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    You will take balinatunfib, which is provided in the form of a film-coated tablet to be taken by mouth.

    The amount of balinatunfib taken will be determined by the study protocol.

  2. Step 2

    <b>monitoring and evaluation</b>

    During the study, the effects of the balinatunfib or a placebo (a substance that does not contain active medicine) will be monitored.

    Health status will be assessed to track safety and how well the body tolerates the medication.

    For those with crohn's disease, progress is measured using the crohn's disease activity index, which is a tool to check how active the disease is, and endoscopic scores, which are used to look at the inside of the digestive tract using a camera.

    For those with ulcerative colitis, progress is measured using the modified mayo score, which is a method used to assess the severity of symptoms and inflammation in the colon.

Who can join the trial?

6 criteria

  • You must have a diagnosis of Crohn's disease (a type of inflammation in the digestive tract) or ulcerative colitis (an inflammation and sores in the lining of the large intestine).
  • You must have finished a previous 52-week study called SPECIFI-CD if you have Crohn's disease, or SPECIFI-UC if you have ulcerative colitis.
  • If you were in a double-blinded part of the previous study, meaning neither you nor the doctors knew which medicine you were receiving, you must have completed the full 52 weeks of treatment.
  • If you were in an open-label part of the previous study, meaning you and your doctors knew which medicine you were receiving, you must have completed the treatment and met specific health goals at the 52-week mark.
  • Men and women must use contraception (methods used to prevent pregnancy, such as birth control) in a way that follows local rules for people in clinical research.
  • Women who wish to participate must not be pregnant or breastfeeding (feeding a baby with milk).

Who cannot join the trial?

6 criteria

  • People with Crohn's disease (a long-term swelling of the digestive tract) who develop a new health problem that prevents them from joining based on specific study rules.
  • People with ulcerative colitis (a long-term swelling of the lining of the large intestine) who develop a new health problem that prevents them from joining based on specific study rules.
  • People who develop a new illness or a change in a current illness that the Investigator (the main doctor in charge of the study) believes would make participating unsafe or would require them to stop taking the IMP (the study medication).
  • People who stopped taking the IMP (the study medication) permanently during the main study, or people who stopped taking it for more than 14 days in a row.
  • People who experienced an adverse event (a side effect or an unexpected medical problem) or a serious adverse event (a medical problem that is severe, such as one that results in hospitalization) that the doctor believes is caused by the study medicine and makes continuing the treatment too risky.
  • People who did not follow the instructions for taking the IMP (the study medication) or their usual treatments, or people who took prohibited medications (medicines that are not allowed during the study) while participating.
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Investigated drugs

Balinatunfib is an experimental medicine taken by mouth in the form of a tablet. It is being studied to see how well it works and how safe it is for long-term use in adults who have Crohn’s disease or ulcerative colitis.

What is already known about the treatment

Balinatunfib - This medication is taken by mouth in the form of a film-coated tablet. It is currently being studied in clinical trials to determine its long-term safety and effectiveness for treating digestive conditions like Crohn's disease and ulcerative colitis. As a targeted therapy, it works at a molecular level to reduce unwanted inflammation in the digestive tract to help calm the immune system. This drug is classified as an experimental anti-inflammatory agent intended for intestinal diseases.

Investigated diseases

  • Crohn's disease

    This is a type of chronic inflammation that can affect any part of the digestive tract. It often involves deep layers of the intestinal wall. The condition can cause swelling and irritation throughout the digestive system. Over time, the inflammation may move from one area to another. It can lead to the formation of narrow passages or sores within the intestines.

  • Ulcerative colitis

    This is a condition characterized by long-lasting inflammation and sores in the lining of the large intestine and rectum. The inflammation is typically continuous and stays within the innermost layer of the intestinal wall. It progresses by causing swelling and redness in the affected areas. This can result in the development of small open sores throughout the colon. The intensity of the inflammation may vary over time.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522511-42-00Protocol codeLTS19689Estimated enrolment371 patientsSponsorSanofi-Aventis Recherche & Developpement

sourced from the EU Clinical Trials Register and site verification

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